An interventional study of Low HIVST kit subsidy and High HIVST kit subsidy in HIV Prevention, sponsored by University of California, San Francisco. Not yet recruiting at 1 site in Tanzania. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
New and innovative strategies are urgently needed to increase the uptake of HIV prevention and sexual and reproductive health services among adolescent girls and young women (AGYW) in sub-Saharan Africa. To ensure the real-world sustainability of free distribution of HIV self-test kits to AGYW by private drug shops and pharmacies, investigators will rigorously test supply-side subsidy structures for shopkeepers' provision of HIV-self test kits to AGYW combined with prosocial motivational supports. The combination of non-monetary and monetary support structures aims to emulate real-world health financing models for public-private partnerships and ultimately aims to improve equity in access to critical prevention services for AGYW at scale.
This is an implementation-effectiveness trial that tests program adoption, implementation, and maintenance of free HIV self-test kit (HIVST) distribution to adolescent girls and young women (AGYW) financed by profits from HIVST kit sales to non-AGYW customers. To initiate adoption, the study will offer pharmacy and drug shopkeepers the opportunity to procure subsidized HIVST to simultaneously distribute to AGYW for free (reimbursed by the study mimicking government-supported provision) and sell to non-AGYW customers for profit, gradually phasing out procurement subsidies over 36 months to test maintenance of the segmented pricing model for real-world sustainability (Aim 1). Investigators will implement non-monetary motivation boosters to sustain shopkeeper engagement over the study period and use mixed-methods to understand shopkeepers' experiences and necessary conditions for program maintenance and provider behavior change (Aim 2), which will inform the co-design of a progressive scale-up plan to achieve national coverage with Tanzanian AGYW, public, and private partnership stakeholders (Aim 3). At the study's conclusion, investigators will have a comprehensive understanding of the support structures shops need to sustain HIVST kit provision for AGYW. Importantly, the study will contribute to generalizable learning about the structures required for commercially sustainable public-private partnerships for high-impact public health interventions.
University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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Exclusion Criteria:
The high subsidy group will start off with a 90% subsidy for purchasing HIV self-test kits to sell in their shops.
Behavioral: High HIVST kit subsidy
The low subsidy group will start off with a 50% subsidy for purchasing HIV self-test kits to sell in their shops.
Behavioral: Low HIVST kit subsidy
The two study groups are the "high" and "low" subsidy groups. The high subsidy group will start off with a 90% subsidy while the low subsidy group will start off with a 50% subsidy. Both study groups will experience decreasing subsidies at each phase of the study.
The two study groups are the "high" and "low" subsidy groups. The high subsidy group will start off with a 90% subsidy while the low subsidy group will start off with a 50% subsidy. Both study groups will experience decreasing subsidies at each phase of the study.
Number of HIVST kits distributed to AGYW per shop month
HIVST kit distribution per shop per month will be tracked via Maisha Meds sales and inventory management system. The data from Maisha Meds will include a tag that identifies the kit recipient as an AGYW and will include the price paid for the HIVST kit ($0 for AGYW).
Time frame: 39 months
Adoption
Proportion of shops continuing to procure HIVST kits throughout the study
Time frame: 39 months
Implementation 1
Proportion of shops that offer free HIVST to AGYW mystery client actors
Time frame: 39 months
Implementation 2
Proportion of shops continuing to provide free HIVST throughout the study period
Time frame: 39 months
Implementation 3
Shopkeeper perspectives on challenges and successes related to providing HIVST kits free to AGYW as measured via surveys and in-depth interviews.
Time frame: 39 months
Maintenance
Proportion of shopkeepers who intend to continue to purchase and sell HIVST kits; Shopkeeper and stakeholder perspectives on subsidies, reimbursements, and sustainability; Reasons for discontinuing the sale of HIVST kits; Proportion of shops continuing to purchase and sell HIVST kits after subsidies end
Time frame: 39 months
Implementation 4
Proportion of shops that sell HIVST to non-AGYW mystery client actors
Time frame: 39 months
Plan to share: Yes — This project will produce survey data, in-depth interview transcripts, and product sales and distribution data. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier (GUID) for the NIMH Data Archive (NDA) will be collected for each subject if possible. This information includes First Name, Middle Name, Last Name, Sex, Date of Birth, City/Municipality of Birth. Because investigators are collecting data from participants in Tanzania, some of this information may be unavailable or may not meet the requirements for the GUID. In that case, pseudoGUIDs will be utilized.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: The research community will have access to data when the award ends. As required by NDA, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available. NDA studies have digital object identifiers (DOI) to aid in findability. Investigators will include that DOI in relevant publications. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
Access criteria: To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Apr 2029, 27 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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